Treats superficial infections of the external auditory canal caused by organisms…. ANDA 40166, held by Chartwell Rx. Acetic Acid, Glacial.
As of Nov 15, 2026, ANDA 40166 (Acetic Acid), held by Chartwell Rx, was first approved by FDA on Jul 26, 1996, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 1996 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetic Acid2% · solution/drops;otic | Acetic Acid, Glacial | Discontinued |
| Aug 5, 1998 | Supplement 1Labeling | Approved | None posted |
| Jul 26, 1996 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
